Apparatus and method for relieving pain using transcutaneous electrical nerve stimulation

ABSTRACT

Apparatus for transcutaneous electrical nerve stimulation in humans, the apparatus comprising: a housing; a stimulation unit mounted within the housing for electrically stimulating nerves; an electrode array releasably mounted to the housing and connectable to the stimulation means, the electrode array comprising a plurality of electrodes for electrical stimulation of nerves; a control unit mounted to the housing and electrically connected to the stimulation unit for controlling at least one characteristic of the stimulation unit; a monitoring unit mounted to the housing and electrically connected to the stimulation unit for monitoring at least one characteristic of the stimulation unit; a user interface unit mounted to the housing and electrically connected to the control unit for controlling the stimulation unit; a display unit mounted to the housing and electrically connected to the control unit and the monitoring unit for displaying the status of the stimulations unit; and a strap attached to the housing; wherein the strap is configured to hold the housing, stimulation unit and electrode array at a specific anatomical location to treat pain.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application is a continuation of pending prior U.S. patentapplication Ser. No. 15/602,611, filed May 23, 2017 by NeuroMetrix, Inc.for APPARATUS AND METHOD FOR RELIEVING PAIN USING TRANSCUTANEOUSELECTRICAL NERVE STIMULATION, which patent application is a continuationof prior U.S. patent application Ser. No. 14/610,757, filed Jan. 30,2015 by NeuroMetrix, Inc. for APPARATUS AND METHOD FOR RELIEVING PAINUSING TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION, which patentapplication is a continuation of prior U.S. patent application Ser. No.13/678,221, filed Nov. 15, 2012 by NeuroMetrix, Inc. and Shai N. Gozaniet al. for APPARATUS AND METHOD FOR RELIEVING PAIN USING TRANSCUTANEOUSELECTRICAL NERVE STIMULATION, which in turn claims benefit of (i) priorU.S. Provisional Patent Application Ser. No. 61/560,029, filed Nov. 15,2011 by Shai N. Gozani for SENSUS OPERATING MODEL; and (ii) prior U.S.Provisional Patent Application Ser. No. 61/657,382, filed Jun. 8, 2012by Shai N. Gozani et al. for APPARATUS AND METHOD FOR RELIEVING PAINUSING TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION.

The five (5) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates generally to Transcutaneous Electrical NerveStimulation (TENS) devices that deliver electrical currents across theintact skin of a patient via electrodes so as to provide symptomaticrelief of chronic pain, and more particularly to the use of TENS devicesto provide symptomatic relief of painful diabetic neuropathy.

BACKGROUND OF THE INVENTION

Diabetic peripheral neuropathy (DPN) is the most common chroniccomplication of diabetes mellitus, which affects about 25 million peoplein the United States and over 300 million people worldwide. DPN affectsthe peripheral nerves, mostly in the feet and lower legs. DPN may leadto a loss of sensation that may trigger foot ulcers requiringamputation. DPN may also lead to severe and debilitating neuropathicpain.

Pain due to DPN is called painful diabetic neuropathy (PDN). PDN affectsabout 50% of people with DPN, and 10-20% of all people with diabetes.PDN is generally treated pharmacologically using drugs that aretypically anti-depressants or anti-epileptics. These drugs may bedifficult to dose and may have substantial side effects in many people.As a result, people with diabetes and PDN are often undertreated, and asmany as 50% of people with PDN may not be receiving any anti-paintherapy. Thus there is a clear need for additional analgesic options forthe management of PDN.

Transcutaneous Electrical Nerve Stimulation (TENS) devices applyelectrical currents to a particular area of the human body in order tosuppress acute and chronic pain. Although not widely used in themanagement of PDN, recent evidence suggests that TENS should beconsidered as an adjunctive or primary therapy for patients with PDN.

The most common form of TENS is called conventional TENS. Inconventional TENS, electrodes are placed on the skin within, adjacentto, or proximal to, the area of pain. Electrical stimulation is thendelivered to the patient through the electrodes, with the electricalstimulation being in the form of low intensity (typically less than50-60 mA), short duration (typically 50-200 μsec) pulses at frequenciestypically between about 10 and 200 Hz.

The physiological principle underlying TENS is that excitation of Aβsensory nerve fibers, primarily the deep tissue afferents, blockstransmission of pain signals to the brain. The most commonly citedmechanism of action is the “gate theory of pain” originally proposed byMelzack and Wall in 1965 (Melzack R, Wall P D. Pain mechanisms: a newtheory. Science. 1965; 150:971-979). In recent years, the molecularmechanisms underlying TENS analgesia have been investigated. It has beendetermined that pain signals are blocked by inhibition of nociceptiveneurons in the spinal cord dorsal horn (DeSantana J M, Walsh D M, VanceC, Rakel B A, Sluka K A. Effectiveness of transcutaneous electricalnerve stimulation for treatment of hyperalgesia and pain. Curr RheumatolRep. 2008; 10(6):492-499). This process is facilitated by descendingsignals from the periaqueductal gray (PAG) and the rostroventral medialmedulla (RVM). There is also evidence that pain signals are interruptedin the peripheral nervous system. Sensory afferent stimulation causesrelease of endogenous opioids that inhibit pain through activation ofδ-opioid receptors. These receptors are located throughout the nervoussystem, including the dorsal horn of the spinal cord. Opioid receptorsare G-protein coupled receptors whose activation decreases neuronalactivity, such as through ion channel regulation. Like the morphinesensitive μ-opioid receptor, the δ-opioid receptor induces analgesia,however, the two receptor subtypes have a different neuroanatomicaldistribution and abuse potential. TENS also increases the extracellularconcentration of the inhibitory neurotransmitter GABA and decreases theconcentration of the excitatory neurotransmitters glutamate andaspartate in the spinal cord dorsal horn.

In a conventional TENS device, an electrical circuit generatesstimulation pulses with specified characteristics. The pulse waveformspecifications include intensity (mA), duration (μsec) and shape(typically monophasic or biphasic). The pulse pattern specificationsinclude frequency (Hz) and length of the stimulation session (minutes).One or more pairs of electrodes, placed on the patient's skin, transducethe electrical pulses and thereby stimulate underlying nerves. Byvarying the intensity of the stimulation pulses and, to a lesser degree,the frequency of the stimulation pulses, the clinical benefit of TENScan be optimized.

There is evidence to suggest that a major barrier to the effective useof TENS therapy is the disproportionate amount of effort needed toregularly apply TENS relative to the amount of pain relief achieved.More particularly, most TENS devices are designed for general purposeuse, i.e., to relieve pain originating from various sources and atvarious anatomical locations. This necessitates a TENS system withmultiple discrete components. For example, the TENS electrodes and theTENS stimulator are typically connected to one another through long leadwires that may be difficult for patients to manage, and may causeembarrassment for the patient if externally visible. The electrodesthemselves are typically generic in form and function, which places theonus on the patient to position the electrodes in a physiologically andclinically optimal arrangement. Because of these issues, general purposeTENS devices typically require extensive patient training andsupervision by medical staff, and even with this training, patients arelikely to forget key steps in the proper use of TENS devices. Bastyr etal. (U.S. Pat. No. 5,487,759) attempted to overcome some of theselimitations by disclosing a stimulator used in conjunction with asupport device, such as an orthopedic brace, with the support deviceproviding mechanical and electrical connections between the stimulatorand electrodes. Nevertheless, there remains a need for TENS devices thatare uniquely designed for specific clinical indications, and whichtherefore render the use of TENS in those applications straightforward,with minimal if any medical support.

To achieve maximum pain relief (i.e., hypoalgesia), TENS needs to bedelivered at an adequate stimulation intensity (Moran F, Leonard T,Hawthorne S, et al. Hypoalgesia in response to transcutaneous electricalnerve stimulation (TENS) depends on stimulation intensity. J Pain.12:929-935). Intensities below the threshold of sensation are notclinically effective. The optimal therapeutic intensity is oftendescribed as one that is “strong but not painful”. Most TENS devicesrely on the patient to set the stimulation intensity, usually through amanual intensity control consisting of an analog intensity knob ordigital intensity control push buttons. In either case, the patient mustmanually increase the intensity of the stimulation to what they believeto be a therapeutic level. Therefore, a major limitation of current TENSdevices is that it may be difficult for many patients to determine anappropriate therapeutic stimulation intensity. As a result, the patientswill either require substantial support from medical staff or they mayfail to get pain relief due to an inadequate stimulation level. In anattempt to improve the likelihood of delivering an appropriatetherapeutic stimulation, some TENS devices allow healthcareprofessionals to pre-program a target stimulation level. For example,Bartelt et al. (U.S. Pat. No. 5,063,929) disclosed a TENS device thatgradually and automatically increases stimulation intensity to aprogrammed target level. However, even when a healthcare professionalprograms the target stimulation level, that level may not suffice afterrepeated use of the TENS device due to changes in the patient's pain andphysiology. In an attempt to overcome some of these issues and automatestimulation intensity control, King et al. (U.S. Pat. No. 7,720,548)proposed a method of regulating stimulation parameters, such as stimulusintensity, based on an electrical impedance signal. However, theclinical usefulness of this method is unclear as the linkage betweenimpedance and therapeutic stimulation intensity is unproven. For thereasons outlined above, current TENS devices suffer from significantlimitations with respect to ensuring that the stimulation intensity iswithin the therapeutic range.

Thus there is a need for a new and improved TENS device which addressesthe issues associated with prior art TENS devices.

SUMMARY OF THE INVENTION

The present invention comprises a novel TENS device which, in itspreferred embodiment, comprises a stimulator designed to be placed onthe patient's upper calf and a pre-configured electrode array designedto provide circumferential stimulation at the area of the upper calf. Akey feature of the present invention is that the TENS device and itsassociated electrode array are designed for easy, rapid, and clinicallyvalid placement of the electrode array by a patient seeking pain reliefin the feet and/or lower legs. In a preferred embodiment, the presentinvention is used for the symptomatic treatment of chronic pain causedby PDN. Furthermore, the present invention is designed to maximizeeffectiveness and usability, and to minimize interference with thepatient's normal daily activities.

With a TENS device, the most important stimulation parameter is theintensity of the stimulation, which must be in the therapeutic range tomaximize pain relief. The present invention provides a novel method fordetermining the stimulation intensity so as to maximize the probabilitythat the stimulation intensity is in the therapeutic range. In apreferred embodiment of the present invention, the patient identifiestheir sensation threshold and then the therapeutic intensity isestimated from the identified sensational threshold. The patient alsohas the option of making further refinements in the stimulationintensity.

Habituation refers to a decrease in sensory perception of a stimulusafter prolonged presentation of the stimulus. In a preferred embodimentof the present invention, in order to overcome habituation, thestimulation intensity is designed to gradually increase throughout theentire therapy session, in contrast to prior art practices of requiringthe patient to manually increase intensity periodically during thetherapy session. The present invention also learns the manner andfrequency of the manual adjustment of the desired stimulation intensityso as to customize the parameter sets that modify stimulation in orderto combat habituation.

In one preferred form of the present invention, there is providedapparatus for transcutaneous electrical nerve stimulation in humans, theapparatus comprising:

a housing;

stimulation means mounted within the housing for electricallystimulating nerves;

an electrode array releasably mounted to the housing and connectable tothe stimulation means, the electrode array comprising a plurality ofelectrodes for electrical stimulation of nerves;

control means mounted to the housing and electrically connected to thestimulation means for controlling at least one characteristic of thestimulation means;

monitoring means mounted to the housing and electrically connected tothe stimulation means for monitoring at least one characteristic of thestimulation means;

user interface means mounted to the housing and electrically connectedto the control means for controlling the stimulation means;

display means mounted to the housing and electrically connected to thecontrol means and the monitoring means for displaying the status of thestimulations means; and

a strap attached to the housing;

wherein the strap is configured to hold the housing, stimulation meansand electrode array at a specific anatomical location to treat pain.

In another preferred form of the present invention, there is providedapparatus for providing transcutaneous electrical nerve stimulation to apatient, the apparatus comprising:

a housing;

stimulation means mounted within the housing for generating electricalpulses;

an electrode array releasably mounted to the housing and connectable tothe stimulation means, the electrode array comprising a plurality ofelectrodes for applying the electrical pulse generated by thestimulation means to the skin of a patient; and

a strap attached to the housing;

wherein the strap is configured to hold the electrode array against theskin of the patient so as to treat pain when the stimulation meansgenerates electrical pulses.

In another preferred form of the present invention, there is providedelectrode array for transcutaneous electrical nerve stimulation inhumans, the electrode array comprising:

a substrate;

at least one electrode mounted to the substrate representing a cathode;

at least one electrode mounted to the substrate representing an anode;

connection means for connecting the electrodes representing the cathodeand anode to electrical stimulation means for electrically stimulatingnerves;

wherein the substrate and the electrodes representing the cathode andanode are designed to provide electrical stimulation at a specificanatomical location and where a minimum distance between electrodesrepresenting the cathode and anode is maintained.

In another preferred form of the present invention, there is provided amethod for determining a therapeutic stimulation intensity fortranscutaneous electrical nerve stimulation in humans, the methodcomprising the steps of:

automatically increasing the stimulation intensity from a firststimulation intensity;

identifying at least one electrotactile perception threshold; and

calculating a therapeutic stimulation intensity from said at least oneelectrotactile perception threshold.

In another preferred form of the present invention, there is provided amethod for determining a therapeutic stimulation intensity fortranscutaneous electrical nerve stimulation in a patient, the methodcomprising the steps of:

applying electrical stimulation to the patient at a first stimulationintensity;

automatically increasing the intensity of the electrical stimulationapplied to the patient from the first stimulation intensity to a secondintensity at which the electrotactile sensation threshold is identified;and

calculating a therapeutic stimulation intensity from said secondintensity level.

In another preferred form of the present invention, there is provided amethod for treating pain in a patient using transcutaneous electricalnerve stimulation, the method comprising the steps of:

automatically determining a therapeutic stimulation intensity;

initiating electrical stimulation at the therapeutic stimulationintensity;

adjusting the therapeutic stimulation intensity under patient control;

automatically increasing the therapeutic stimulation intensity at apre-determined rate; and

continuing electrical stimulation for a period of time.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a schematic view showing a novel TENS apparatus formed inaccordance with the present invention;

FIG. 2 is a schematic view showing an electrode array being electricallyand mechanically connected to the stimulator of the TENS apparatus shownin FIG. 1 ;

FIG. 3 is a schematic view showing the TENS apparatus of FIG. 1 mountedto the upper calf of a patient;

FIG. 4 is a schematic view showing the biphasic, symmetrical,rectangular pulses with regulated current generated by the stimulator ofthe TENS apparatus of FIG. 1 ;

FIG. 5 is a schematic view showing the pulse train provided by thestimulator of the TENS apparatus of FIG. 1 ;

FIG. 6 is a schematic view of the underside of the electrode array ofthe TENS apparatus of FIG. 1 ;

FIG. 7 is a photograph showing the top side and the underside of theelectrode array of the TENS apparatus of FIG. 1 ;

FIG. 8 is a schematic graph showing the relationship betweenelectrotactile perception and electrical stimulation intensity; and

FIG. 9 is a schematic view showing the overall operation of the TENSapparatus of FIG. 1 .

DETAILED DESCRIPTION OF THE INVENTION

Looking first at FIG. 1 , there is shown a novel TENS apparatus 100which comprises one preferred form of the present invention. TENSapparatus 100 generally comprises three components: a stimulator 105, astrap 110, and an electrode array 120.

Stimulator 105 comprises three mechanically and electricallyinter-connected compartments 101, 102, and 103. Compartments 101, 102,103 are inter-connected by hinge mechanisms 104, thereby allowing TENSassembly 100 to conform to the curved anatomy of a user's leg. In thepreferred embodiment, compartment 102 contains stimulation hardware(except for a battery) and user interface elements 106, 108. In thepreferred embodiment, compartments 101 and 103 are smaller, auxiliarycompartments that house a battery for powering the stimulation hardwareand other ancillary elements.

As shown in FIG. 2 , electrode array 120 comprises electrical contacts210, 212 that snap into mating ports 130, 132 provided on the undersideof central stimulator compartment 102. When snapped together, stimulator105 and electrode array 120 are mechanically and electrically connected.This direct electro-mechanical connection between stimulator 105 andelectrode array 120 eliminates the need for inconvenient lead wiresfound in other TENS devices.

Central stimulator compartment 102 also has a USB port 133 on itsunderside for (i) charging the battery contained in one of the outboardcompartments 101, 103, (ii) downloading of utilization data, (iii)configuring the stimulator 105, and (iv) uploading of software upgrades.In the preferred embodiment, USB port 133 is not electrically isolatedfrom the stimulator hardware in order to simplify the design and lowermanufacturing costs. However, the location of USB port 133 on theunderside of central stimulator compartment 102 prevents use of the USBport when an electrode array 120 is attached to stimulator 105, e.g., asmay be understood from FIG. 2 . As a result, electrical safety ismaintained because stimulator 105 cannot be used to deliver stimulationto a patient via electrode array 120 while stimulator 105 issimultaneously connected to another device, e.g., a power supply, viaUSB port 133.

Looking again at FIG. 1 , stimulator 105 includes a push button 106 forcontrol of electrical stimulation, and LEDs 108 for indicatingstimulation status and providing other feedback to the patient. Althoughthe preferred embodiment shown in FIG. 1 comprises a single push button106 and two LEDs 108, other constructions may also be used, e.g., two ormore push buttons, etc. Additional user interface elements (e.g., an LCDdisplay, audio feedback through a beeper or voice output, haptic devicessuch as a vibrating motor, etc.) have been contemplated and areconsidered to be within the scope of the present invention. In thepreferred embodiment, main compartment 102 of stimulator 105 includes anaccelerometer (not shown), preferably in the form of a semiconductorchip, to detect user gestures such as tapping (or slapping) on centralcompartment 102. Additional uses for the accelerometer include thedetection of certain movement characteristics of TENS apparatus 100, andtherefore identification of patient orientation and activity, such aslying, standing, walking, gait, etc., which permits modifying thestimulation characteristics of stimulator 105 in order to optimizestimulation for the identified patient state. In addition to the userinterface elements noted above, the electrical stimulation itself canserve a user interface function. More particularly, the patient willgenerally recognize changes in the stimulation pattern. Thus, forexample, the stimulator 105 can indicate to the patient that thestimulation intensity has reached a maximum value by pulsing stimulationon and off with a fixed on and off period (e.g., 0.5 seconds) for ashort period of time (e.g., 3 seconds).

In the preferred embodiment, and still looking now at FIG. 1 , the userinterface elements (e.g., push button 106 and LEDs 108) are physicallylocated on stimulator 105. In alternative embodiments, one or more ofthe user interface components may be remotely located. These remote userinterface elements may be connected to stimulator 105 through a varietyof means including a physical link such as a wire, a wireless link suchas a Bluetooth® connection, an optical link such as an infra-red (IR)connection, etc. These remote user interface elements may be located ondedicated devices specifically designed to control stimulator 105 suchas a custom remote control, or they may be incorporated into existingdevices used by the patient such as a smart phone, a tablet computer,etc.

As seen in FIG. 3 , strap 110 serves to securely and comfortably attachstimulator 105 to the patient's leg in the upper calf region 140. In thepreferred embodiment, strap 110 is constructed from material thatincludes Velcro® which allows the device to be easily secured to avariety of different calf sizes. It is also possible to make the strapremovable from stimulator 105 and thereby offer straps of varying sizesto more readily adapt to particularly small or large calves. Strap 110may also include a mechanism (not shown), such as a clip, for holdingthe ends of electrode array 120 in place. Strap 110 may also includeelectronic means (not shown) that determine calf circumference and/orother biometric data (e.g., skin temperature) and communicate this datato stimulator 105 for optimization of stimulation parameters.

The preferred embodiment of the invention is designed to be worn on thepatient's upper calf 140 as shown in FIG. 3 . A patient may wear a TENSapparatus 100 on one or both legs depending on the nature and level oftheir pain, and as directed by their physician. In the case of two TENSapparatus 100, the devices may communicate with one another through awireless link to synchronize their operation. TENS apparatus 100,comprised of stimulator 105, electrode array 120 and strap 110, issecured to upper calf 140 by placing the apparatus in position and thentightening strap 110 so as to secure electrode array 120 against theskin of the patient. The particular rotational disposition of TENSapparatus 100 on upper calf 140 is not clinically important as theconstruction and operation of electrode array 120 is intentionallydesigned to be independent of the exact rotational position of TENSapparatus 100. More particularly, and as will hereinafter be discussedin further detail, electrode array 120 is deliberately sized andconfigured so that it will apply appropriate electrical stimulation tothe appropriate anatomy of the patient regardless of the specificrotational position of TENS apparatus 100 on the calf of the patient.

Stimulator 105 is a microprocessor-controlled circuit which generatesbiphasic, symmetrical, rectangular pulses with regulated current, asshown in FIG. 4 . This pulse waveform is charge-balanced which preventsiontophoretic build-up under the electrodes of the electrode array 120that can lead to skin irritation and potential skin damage. Regulatedcurrent pulses provide more stable stimulation than regulated voltagepulses, because the stimulation current is independent of theelectrode-skin impedance, which typically changes during the course of atherapy session. In order to address a wide variety of skin types andelectrode quality (due to repeat use and air exposure), the maximumoutput voltage is 100V and the maximum output current is 100 mA.Finally, the pulse pattern is continuous stimulation with randomlyvarying inter-pulse intervals such that the frequency of stimulation hasa uniform probability distribution between 60 Hz and 100 Hz.Alternatively, the frequency of stimulation may have a Gaussianprobability distribution between 60 Hz and 100 Hz, or some otherprobability distribution. The benefit of providing frequency stimulationwith randomly varying inter-pulse intervals (versus frequencystimulation with constant inter-pulse intervals) is that the former typeof stimulation may lead to less nerve habituation, which is aphysiological decrease in nerve responsiveness to stimulation.Preferably the gap between the positive and negative phases of the pulsepattern is relatively small and uniform, although the gap may beomitted, or modified, if desired. In this respect it should beappreciated that the presence of the gap between the positive andnegative phases of the pulse pattern is primarily a consequence ofsimplified circuit design. Although the preferred embodiment ofstimulator 105 has specific technical characteristics, other technicalspecifications (such as for the pulse waveform shape, maximum outputvoltage, maximum output current, and pulse pattern) have beencontemplated and are considered to be within the scope of the presentinvention. In another embodiment, the stimulation attributes ofstimulator 105 are programmable, with the stimulator being connectable(such as through the USB port) to a computer or mobile device (e.g.,smart phone, tablet computer, etc.) running appropriate setup software.In this fashion, the stimulation attributes of stimulator 105 can becustomized to the user's pain characteristics, physiology, andpreferences.

FIG. 5 is a schematic view of an exemplary pulse train 480 provided bystimulator 105 during a therapy session and shows the waveform of twoindividual pulses 490, each of which has the spaced biphasic waveformshown in FIG. 4 . Pulses of fixed or randomly varying frequenciespersist throughout the therapy session duration 482. The intensity ofthe stimulation (i.e., the amplitude of the current delivered bystimulator 105) is adjusted in response to patient input and forhabituation compensation, as is described below.

A schematic of the preferred embodiment of electrode array 120 is shownin FIG. 6 . A photograph showing the top side 222 of electrode array 120and the underside 220 of electrode array 120 is shown in FIG. 7 .Electrode array 120 preferably comprises four discrete electrodes 202,204, 206, 208, preferably each electrode having an equal surface area.Electrodes 202, 204, 206, 208 are connected in pairs so that electrodes204 and 206 (representing the cathode) are electrically connected to oneanother (e.g., via connector 205), and so that electrodes 202 and 208(representing the anode) are electrically connected to one another(e.g., via connector 207). It is understood that when the polarity ofthe electrical pulse is reversed, the roles of the cathode and anodeelectrodes are also reversed. It should be appreciated that electrodes202, 204, 206 and 208 are appropriately sized, and connected in pairs,so as to ensure adequate skin coverage regardless of the rotationalposition of electrode array 120 on the leg of a patient. Furthermore, itshould be appreciated that electrodes 202, 204, 206 and 208 are notconnected in an interleaved fashion, but rather are connected so thatthe two inside electrodes 204 and 206 are connected to one another, andso that the two outside electrodes 202 and 208 are connected to oneanother, so as to ensure that if the two outer electrodes 202 and 208should inadvertently come into contact with one another, such as mightoccur in a patient with a thin calf, the electrode array will not beshorted out. Electrical current (i.e., for electrical stimulation to thetissue) is provided to the electrode pairs by connectors 210, 212 (seealso FIG. 2 ) which mate with complementary connectors 130, 132 onstimulator 105 (see also FIG. 2 ). Connector 210 is electricallyconnected with electrodes 204 and 206, and connector 212 is electricallyconnected with electrodes 202 and 208. Stimulator 105 generateselectrical currents that are passed through electrodes 204, 206 andelectrodes 202, 208 via connectors 210, 212, respectively. Theindividual electrodes 202, 204, 206, 208 are preferably constructed froma hatched silver pattern overlaid with a conductive hydrogel. Thebacking 214 for electrode array 120 is preferably Mylar on which theaforementioned silver patterns are printed. Electrical connectionsbetween the electrodes 202, 204, 206, 208 and the connectors 210, 212(i.e., connectors 205, 207) are formed by printed silver traces whichare covered with an insulating material. Additional embodiments ofelectrode array 120 have been contemplated including the use of varyingnumbers of electrodes, different electrode sizes and differentinter-electrode spacing, and alternative electrode silver patterns suchas a solid, and are considered to be within the scope of the presentinvention.

Electrode array 120 is designed for circumferential placement around thepatient's upper calf as shown in FIG. 3 . The design of electrode array120 ensures that a minimum distance is always maintained between theelectrodes 204, 206 forming the cathode and the electrodes 202, 208forming the anode. In the preferred embodiment, this minimum distance is40 mm. In this respect it should be noted that a minimumcathode-to-anode distance is critical for proper TENS operation becauseif the cathode and the anode are too close to one another, thestimulation current does not penetrate sufficiently deeply into thetissue and the ability to stimulate nerves is compromised.

When stimulator 105 and electrode array 120 are connected together asshown in FIG. 2 , and placed on the patient (using strap 110) as shownin FIG. 3 , the individual electrodes 202, 204, 206, 208 are positionedto deliver stimulation to the L4, L5, S1 and S2 sensory dermatomes whichprovide sensation to the foot and lower leg. As a result, the inventionis particularly suitable for providing analgesia in the foot and lowerleg, which supports its preferred use for the symptomatic treatment ofchronic pain due to PDN.

The use of the preferred embodiment of the present invention isstraightforward. The user snaps an electrode array 120 into stimulator105 (FIG. 2 ), thereby establishing a secure mechanical and electricalcontact between the two components. Using strap 110, this assembly isthen placed on the upper calf of the patient (FIG. 3 ) so that theelectrodes of electrode array 120 are securely disposed against the skinof the patient. Stimulation is initiated by pressing the control pushbutton 106. Upon completion of the therapy session, TENS apparatus 100is removed from the patient and electrode array 120 is detached fromstimulator 105. Electrode array 120 may be used multiple times on asingle patient.

A major objective of the present invention is to simplify the userinterface, and therefore a one-button interface is preferred.Conventional TENS devices typically have multiple user interfaceelements consisting of on/off switches, buttons to increase/decrease thestimulation intensity, dials to change the stimulation intensity, andother controls to regulate device function. The correct use of suchprior art user interfaces requires that the patient have unfetteredphysical and visual access to the device, which limits placement of thedevice to certain anatomical locations, such as on a belt clip. Bycomparison, the present invention utilizes a simple one-button interfacethat does not require visual confirmation and is easily operated withthe device placed anywhere on the body, including the lower leg as shownin FIG. 3 . In the preferred embodiment of the present invention, whichutilizes a one-button interface, the device is powered on (either from alow power stand-by state or from an off-state) by a button press.Stimulation intensity is controlled through short and long buttonpresses. More particularly, holding the button down increases thestimulation intensity as long as the button is depressed, such as at therate of 1 milliamp per second. Pressing and quickly releasing (i.e.,“tapping”) the button decreases the stimulation intensity by a fixedamount, such as 1 milliamp per button press or by a fixed percentage,such as 2% per button press. In this fashion, the stimulation intensitycan be easily controlled by the patient with a single push button (i.e.,push button 106). The present invention further discloses the provisionof an accelerometer to detect user gestures such as slapping (ortapping) the stimulator enclosure 102. In the preferred embodiment, thedetection of a slap immediately stops stimulation.

There is no universal TENS stimulation intensity that provides aneffective, yet tolerable, therapeutic dose for all patients. Therefore,in order to obtain the clinical benefit of TENS therapy, it is essentialto set the stimulation intensity to a patient-specific level. Astimulation intensity that elicits a “strong but not painful” sensationwill provide effective pain relief, and is therefore suggestive of anintensity that is within the therapeutic window. The traditionalapproach in TENS is for the medical staff to train patients on how tomanually increase the intensity of the TENS stimulation until thepatients perceive the desired “strong but not painful” sensation. It isthen the responsibility of the patient to thereafter perform thisprocedure as necessary, e.g., at home when TENS therapy is needed.However, this prior art approach requires the use of expensive medicalresources (i.e., medical staff time) and is error prone inasmuch aspreviously-trained patients may forget how to determine an appropriatetherapeutic intensity. As a result, a major objective of the presentinvention is to automatically and reliably set the stimulation intensitywithin the therapeutic range.

The present invention discloses a method for automatically setting thestimulation intensity to a therapeutic level, a procedure which issometimes hereinafter referred to as “configuration”. This method isbased on the concept of mapping a patient's electrotactile perceptionscale, on which the “strong but not painful” sensation is represented,to an electrical stimulation intensity scale as measured in milliamps.In this respect, the term “electrotactile” is meant to refer to apatient's sensation of electrical stimulation. There are three keymeasurable electrotactile perception levels: electrotactile sensationthreshold (i.e., the lowest level of electrical stimulation which thepatient can sense), electrotactile pain threshold (i.e., the level ofelectrical stimulation which causes pain to the patient), andelectrotactile tolerance threshold (i.e., the maximum level ofelectrical stimulation which can be tolerated by a patient). An optimalTENS stimulation intensity is located between the electrotactilesensation threshold and the electrotactile pain threshold.

FIG. 8 shows a curve 300 illustrating the relationship betweenelectrical stimulation intensity 302 and electrotactile perception 304.The slope of curve 300 is steep near the electrotactile sensationthreshold 306, so the range 308 of stimulation intensities, I(s), whichmay first elicit sensation in the patient is generally narrow. As aresult, the electrotactile sensation threshold 306, and thecorresponding stimulation intensity 308, i.e., I(s), can be reliablydetermined. The electrotactile pain threshold 310, which is defined asthe level where electrical stimulation sensation changes fromcomfortable to painful, is not as well-defined and is influenced bymultiple physiological and psychological factors. As a result, the curve300 is not as steep in the electrotactile pain threshold region 310 asin the electrotactile sensation threshold region 306. This can lead to awide range 312 of stimulation intensities, I(p), at which the transitionto pain occurs. For this reason, it may be difficult to reliably measurethe electrotactile pain threshold 310, and the corresponding stimulationintensity 312. Another drawback with measuring the electrotactile painthreshold 310 is that it necessitates stimulation with currentintensities that are at the upper limit of the patient's comfortablerange and, due to the variation in the exact pain threshold 310, mayoccasionally be perceived as painful. Consequently, a patient mayconsistently underestimate his/her pain threshold, leading to astimulation level which is below the optimal therapeutic range if thetherapeutic level is estimated from the electrotactile pain threshold310.

Since the stimulation intensity I(s) associated with the electrotactilesensation threshold 306 can be reliably estimated, a target therapeuticstimulation intensity I(t), which provides a “strong but not painful”sensation 314, may be calculated by adding an intensity offset I(o) 318to the stimulation intensity I(s) associated with the electrotactilesensation threshold. In other words, where I(s) is the stimulationintensity associated with the electrotactile sensation threshold, anintensity offset I(o) may be added to the stimulation intensity I(s) soas to determine the stimulation intensity I(t) which is “strong but notpainful”, i.e., therapeutically effective and yet comfortable for thepatient. This is a new and innovative method for determining astimulation intensity that is strong but not painful to the patient.

A preferred embodiment of this procedure for automatically setting thestimulation intensity to a therapeutic level is to gradually increasethe stimulation intensity from 0 mA until the patient indicates that thestimulation is first felt, i.e., that the electrotactile sensationthreshold has been reached, such as by using the push button 106. In apreferred embodiment, the stimulation intensity is increased in ageometric progression. For example, the stimulation intensity mayincrease by 5% every second (i.e., stimulation intensity is 1.05 timesthe prior stimulation intensity). The benefit of a geometric progressionis that it better matches the exponential relationship of stimulusintensity and electrotactile sensation (i.e., the so-called“psychophysical power law”) than does a linear increase in intensity(e.g., 1 mA per second). The procedure can be repeated multiple times toallow a more accurate estimate of the electrotactile sensation thresholdand the associated intensity I(s), such as by taking the mean or medianof multiple measurements. In a preferred embodiment, the firstdetermination of the electrotactile sensation threshold is discardedbecause the patient may not be familiar with the perception ofelectrical stimulation and may therefore underestimate or overestimatethe correct level.

An increment of stimulation intensity, i.e., an intensity offset I(o),is then added to the stimulation intensity I(s) associated with theelectrotactile sensation threshold so as to estimate the therapeuticintensity, I(t), 316.

In a preferred embodiment, the stimulation intensity offset I(o) is aconstant for all patients. Because sensory perception typically variesin a logarithmic fashion, the relationship between the therapeuticintensity, I(t), and the sensation threshold intensity, I(s), isexpressed as a ratio (e.g., 2), or in decibels (e.g., 6 dB), where theratio=10^((dB/20)).

In another preferred embodiment, the stimulation intensity offset I(o)varies according to manual changes in the stimulation intensity made bythe patient. As an example, if, after a first determination of thetherapeutic intensity (i.e., by adding a default offset I(o) to thestimulation intensity I(s) associated with the electrotactile sensationthreshold 306), the patient then manually increases the stimulationintensity (as determined by the above procedure) during a subsequenttherapy session, it is likely that the optimal intensity offset for thatpatient is larger than the default offset. Therefore, in a subsequentdetermination of the therapeutic intensity, a larger stimulationintensity offset is used. Similarly, if, after a first determination ofthe therapeutic intensity (i.e., by adding a default offset I(o) to thestimulation intensity I(s) associated with the electrotactile sensationthreshold 306), the patient then manually decreases the stimulationintensity during a subsequent therapy session, it is likely that theoptimal intensity offset for that patient is smaller than the defaultvalue. Therefore, in a subsequent determination of the therapeuticintensity, a smaller stimulation intensity offset is used. In thisfashion, the therapeutic intensity estimated from the sensationthreshold is adaptive and responsive to the patient's input.

Additional embodiments of the present invention have been contemplatedwherein the stimulation intensity offset I(o) is determined as afunction of demographic or biometric variables such as the gender of thepatient, circumference of the calf of the patient, calf temperature, andlevel and type of activity (e.g., rest, sleep, walking). As an example,it is known that males have higher electrotactile thresholds thanfemales, and therefore the stimulation intensity offset I(o) can be setto gender specific values wherein the male intensity offset is greaterthan the female intensity offset. As another example, a patient with alarge calf is likely to require a higher stimulation intensity levelthan a patient with a smaller calf due to the distance between the skinand the underlying nerves which are to be stimulated. Therefore, thecalf size (which, in one preferred form of the invention, may beelectronically measured by the strap 120 and communicated to thestimulator 105) may be used as an input to determine the stimulationintensity offset to be used for that patient. As yet another example, itis known that electrotactile thresholds are inversely related to thetemperature of the patient, which may be approximated by measuring thepatient's skin surface temperature. Therefore, the stimulation intensityoffset can be increased (for lower patient temperatures) or decreased(for higher patient temperatures) as a function of the skin surfacetemperature to address these temperature-dependent changes inelectrotactile perception. The skin surface temperature can be measuredwith a non-contact infrared thermosensor (e.g., MLX90615, MelexisSemiconductors, Belgium) or a contact digital thermosensor (e.g.,DS1820, Maxim, Inc., Sunnyvale, Calif.), which can be embedded in thestrap 110 or the enclosure of stimulator 105. Although the use of skinsurface temperature is described with respect to estimation of thetherapeutic intensity from the sensation threshold, additionalembodiments of the present invention have been contemplated in whichskin surface temperature is used to continuously adjust the stimulationintensity during a therapeutic session to account for temperaturechanges.

Once a therapeutic intensity level I(t) is determined, TENS apparatus100 is ready to be used for therapeutic purposes. The patient mayre-establish the therapeutic intensity, i.e., I(t), from time to time.It should be noted that a TENS device can be used without automaticdetermination of the therapeutic intensity level by using a universalintensity level, such as a maximum safe therapeutic intensity. However,such a fixed approach is severely limited as described above.

In a preferred embodiment, when a patient initiates a treatment session,the stimulation intensity will steadily ramp up to the target intensity,I(t), 316, where the target intensity has been determined by previouslyconducting electrotactile perception mapping for that patient (whichidentified the stimulation intensity I(s) associated with the sensationthreshold) and then adding the desired intensity offset I(o) so as toestablish the therapeutic stimulation intensity I(t) to be used for thatpatient. The stimulation intensity should gradually increase to thetarget intensity (i.e., the therapeutic stimulation intensity) I(t) overa sufficiently long period of time such that the patient will not besurprised by the stimulation or become uncomfortable with thestimulation. In the preferred embodiment, the stimulation intensityincreases to the target intensity over a time period of 1 minute, andthis is done in three phases. In the first phase, the stimulationintensity increases to 90% of the sensation threshold in 5 seconds.These intensity levels are sub-sensation threshold and therefore shouldnot be perceived by the patient. In the second phase, the stimulationintensity increases from 90% to 112% (+1 dB) of the sensation thresholdin 10 seconds. These stimulation intensities are near the sensationthreshold and should be minimally perceived by the patient and will notbe uncomfortable. In the third and final phase, the stimulationintensity increases from 112% of the sensation threshold to the targetintensity (i.e., the therapeutic stimulation intensity). This gradualincrease in stimulation intensity gives the patient the opportunity tobecome comfortable with the stimulation and avoids startling thepatient.

In the preferred embodiment, the patient may further refine thestimulation intensity by increasing or decreasing the stimulationintensity using push button 106. In a preferred embodiment, thestimulation intensity cannot be decreased below an intensity “floor”which ensures that the stimulation intensity remains in a likelytherapeutic range. As an example, the intensity floor can be set to 12%(1 dB) above the sensation threshold.

A novel benefit of determining the electrotactile sensation threshold inthe foregoing manner is that the likely therapeutic benefit of thestimulation intensity used by the patient, particularly if manuallymodified by the patient from the automatic level determined as describedabove, can be evaluated. In the preferred embodiment, the utilizationdata stored by the stimulator 105 includes the stimulation intensity ofeach therapy session. As such, when the utilization data is uploaded toa computer, the average therapy level for that patient can be calculatedand reported as, for example, a decibel level over the sensationthreshold. The patient's physician can then assess this value againstthe pain relief obtained by the patient and make appropriate clinicalrecommendations. For example, if the patient has a low therapy level(e.g., 2 dB above the sensation threshold intensity, I(s)) and thepatient is not obtaining pain relief, the physician may then suggestthat the patient re-establish their therapeutic intensity using theconfiguration procedure described above.

Habituation refers to a decrease in the sensory perception of a stimulusby the patient after the prolonged presentation of the stimulus to thepatient. As applied to TENS therapy, habituation may cause a decrease inpain relief following prolonged stimulation at the same therapeuticintensity. In traditional TENS devices, patients are instructed tomanually increase the stimulation intensity from time to time if theirperception of the stimulation decreases. This places the onus on thepatient, who is forced to repeatedly re-engage with the TENS device, orthey may entirely forget to adjust the intensity of the TENS device.

Significantly, the present invention includes a method for providingautomatic habituation compensation, which consists of an automaticgradual increase in the stimulation intensity over the course of astimulation session. In the preferred embodiment, the stimulationintensity is increased geometrically with time. In other words, thestimulation intensity is multiplied by a fixed factor per unit time. Forexample, the stimulation intensity may be increased by the factor 1.004for every minute of a therapy session. This equates to an approximately27% (2 dB) increase in stimulation intensity over a 60 minute therapysession. In another embodiment, the stimulation intensity is increasedby a fixed amount, such as 0.5 milliamps, for every minute of thetherapy session. In another embodiment, the rate of increase is adjustedto account for manual changes in the stimulation intensity. For example,if the patient decreases the stimulation intensity in the middle of thetherapy session, then the automatic rate of increase may be too high forthis patient and should be decreased for subsequent therapy sessions.Similarly, if the patient increases the stimulation intensity in themiddle of the therapy session, then the automatic rate of increase maybe too low for this patient and should be increased for subsequenttherapy sessions. In this fashion, the automatic habituationcompensation is adaptive and responsive to the patient's physiology.

FIG. 9 provides an overall view of the operation of the preferredembodiment of the present invention. First, as shown at 450, thepatient's electrotactile perception thresholds are mapped to stimulationintensities, i.e., the electrotactile sensation threshold is mapped to astimulation intensity I(s), and the therapeutic stimulation intensityI(t) is determined, i.e., by adding an intensity offset I(o) to thestimulation intensity I(s). Thus, upon entering the first therapysession 465, the therapeutic intensity level has already beenautomatically calculated for that patient. During the first phase 462 offirst therapy session 465, the patient may adjust the stimulationintensity using the user interface controls (e.g., push button 106). Thestimulation intensity at the end of the this first phase 462, whichtypically lasts for 3 minutes, is stored and becomes the therapeuticintensity level for the next therapy session 467. Habituationcompensation, as previously described, occurs throughout the rest of thetherapy session (i.e., during phase 464 of first therapy session 465)and subsequent therapy sessions 467. The patient has the option ofrepeating the electrotactile perception mapping phase 450, which willinvoke a recalculation of the therapeutic stimulation intensity I(s),after one or more therapy sessions 467.

MODIFICATIONS OF THE PREFERRED EMBODIMENTS

It should be understood that many additional changes in the details,materials, steps and arrangements of parts, which have been hereindescribed and illustrated in order to explain the nature of the presentinvention, may be made by those skilled in the art while still remainingwithin the principles and scope of the invention.

What is claimed is:
 1. A method for setting the therapeutic stimulationintensity for transcutaneous electrical nerve stimulation in humans, themethod comprising the steps of: initiating a transcutaneous electricalnerve stimulation session for a user at a first therapeutic stimulationintensity; automatically adjusting the first therapeutic stimulationintensity at a pre-determined adjustment rate, wherein thepre-determined adjustment rate is fixed during the transcutaneouselectrical nerve stimulation session; responding to commands from theuser for manual changes in the therapeutic stimulation intensity;continuing the transcutaneous electrical nerve stimulation session for aperiod of time; and updating at least one of the first therapeuticstimulation intensity and the pre-determined adjustment rate for futuretranscutaneous electrical stimulation sessions based on accumulativechanges initiated by the user.
 2. A method according to claim 1 whereinthe first therapeutic stimulation intensity is updated for futuretranscutaneous electrical stimulation sessions based on accumulativechanges initiated by the user.
 3. A method according to claim 1 whereinthe pre-determined adjustment rate is updated for future transcutaneouselectrical stimulation sessions based on accumulative changes initiatedby the user.
 4. A method according to claim 1 wherein the firsttherapeutic stimulation intensity and the pre-determined adjustment rateare both updated for future transcutaneous electrical stimulationsessions based on accumulative changes initiated by the user.
 5. Amethod according to claim 1 wherein the first therapeutic stimulationintensity is determined automatically based on an electro-tactilesensation threshold indicated by the user.
 6. A method according toclaim 1 wherein the automatic intensity adjustment is to increase theintensity by a multiplicative factor at a time interval.
 7. A methodaccording to claim 6 wherein the time interval is one minute.
 8. Amethod according to claim 6 wherein the multiplicative factor for futurestimulation sessions is updated according to a target stimulationintensity level as projected by the multiplicative factor, an actualstimulation intensity level as modified by the user, and the differencebetween these intensity levels at the end of a current stimulationsession.
 9. A method according to claim 6 wherein the multiplicativefactor is 1.004 and the time interval is 1 minute.
 10. A methodaccording to claim 1 wherein the automatic intensity adjustment is toincrease the intensity by an additive factor at a time interval.
 11. Amethod according to claim 1 wherein the period of time is the lesser of60 minutes and a lower value due to a stimulation exit event.
 12. Amethod according to claim 11 wherein the stimulation exit event istriggered by a user action.
 13. A method according to claim 11 whereinthe stimulation exit event is triggered by a stimulation errorcondition.
 14. A method for setting the therapeutic stimulationintensity for transcutaneous electrical nerve stimulation in humans, themethod comprising the steps of: initiating transcutaneous electricalnerve stimulation to a user at a first therapeutic stimulationintensity; automatically adjusting the therapeutic stimulation intensityat a pre-determined adjustment rate; responding to commands from theuser for manual changes in the therapeutic stimulation intensity;continuing the transcutaneous electrical nerve stimulation for a periodof time; and updating at least one of the first therapeutic stimulationintensity and the pre-determined adjustment rate for future electricalstimulation sessions based on accumulative changes initiated by theuser; wherein the first therapeutic stimulation intensity is determinedautomatically based on an electro-tactile sensation threshold indicatedby the user.
 15. A method for setting the therapeutic stimulationintensity for transcutaneous electrical nerve stimulation in humans, themethod comprising the steps of: initiating transcutaneous electricalnerve stimulation to a user at a first therapeutic stimulationintensity; automatically adjusting the therapeutic stimulation intensityat a pre-determined adjustment rate; responding to commands from theuser for manual changes in the therapeutic stimulation intensity;continuing the transcutaneous electrical nerve stimulation for a periodof time; and updating at least one of the first therapeutic stimulationintensity and the pre-determined adjustment rate for future electricalstimulation sessions based on accumulative changes initiated by theuser; wherein the automatic intensity adjustment is to increase theintensity by a multiplicative factor at a time interval.
 16. A methodaccording to claim 15 wherein the time interval is one minute.
 17. Amethod according to claim 15 wherein the multiplicative factor forfuture stimulation sessions is updated according to a target stimulationintensity level as projected by the multiplicative factor, an actualstimulation intensity level as modified by the user, and the differencebetween these intensity levels at the end of a current stimulationsession.
 18. A method according to claim 15 wherein the multiplicativefactor is 1.004 and the time interval is 1 minute.
 19. A method forsetting the therapeutic stimulation intensity for transcutaneouselectrical nerve stimulation in humans, the method comprising the stepsof: initiating transcutaneous electrical nerve stimulation to a user ata first therapeutic stimulation intensity; automatically adjusting thetherapeutic stimulation intensity at a pre-determined adjustment rate;responding to commands from the user for manual changes in thetherapeutic stimulation intensity; continuing the transcutaneouselectrical nerve stimulation for a period of time; and updating at leastone of the first therapeutic stimulation intensity and thepre-determined adjustment rate for future electrical stimulationsessions based on accumulative changes initiated by the user; whereinthe automatic intensity adjustment is to increase the intensity by anadditive factor at a time interval.